RBR-53r6n7
Recruiting
N/A
Implant of the Inovare® Transfemoral Transcatheter ValveFeasibility and Verification of Safety and Efficacy Clinical Trial
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP0 sitesFebruary 17, 2020
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with significant calcified degenerative native aortic valve stenosis; Multidisciplinary evaluation by the Heart Team that concludes that the patient has a high surgical risk for aortic valve replacement or the presence of extreme fragility or the presence of comorbidities or aorta in porcelain or hostile chest; Symptoms of heart failure in NYHA functional class \= II; Aortic valve ring with an average diameter between 17\.3 and 28\.6 mm, documented by imaging method, suitable for positioning and accommodating the Inovare® prosthesis; Coronary ostia height\> 10 mm or presence of coronary graft that prevents the occurrence of acute myocardial ischemia due to coronary occlusion after the valve is released; Arterial femoral access route considered adequate for the progression of the vascular introducer and prosthesis\-balloon system; Signed Free and Informed Consent Form.
Exclusion Criteria
- •Clinicals: Hemodynamic instability with the need for vasoactive drugs or circulatory support; Valve procedure with clinical need to be performed in times of urgency or emergency (non\-elective); Left ventricular ejection fraction \<30%; Chronic dialysis renal failure; Acute renal failure with serum creatinine that has not yet returned to baseline levels; Clinical or biological signs of infection with systemic repercussions; Endocarditis \<12 months; Coronary disease requiring elective revascularization during or after the valve procedure; Evidence of myocardial infarction in less than one month; Stroke or recent transient ischemic attack (in the last 6 months); Hypersensitivity or contraindication to the administration of heparin, ticlopidine or clopidogrel or to the radiopaque contrast medium; Anemia, thrombocytopenia or hyperthrombocytosis; Need for chronic anticoagulation for other causes; Active peptic disease, gastrointestinal bleeding \<3 months or previously diagnosed hemorrhagic diasteses; Life expectancy less than 12 months due to non\-heart disease or other comorbidities.
- •Anatomical / morphological: Valve ring diameter less than or equal to 17\.2 mm or greater or equal to 28\.7 mm; Iliac\-femoral access route, with extreme tortuosity or calcification or reduced luminal diameter, which prevents the safe progression of the arterial introducer and delivery system with the prosthesis; Presence of sessile and unstable atheroma in the ascending aorta and / or aortic arch detected by imaging methods; Obstructive hypertrophic cardiomyopathy or severe obstruction of the left ventricular outflow tract, with no possibility of balloon dilation; Previous aortic or mitral valve procedure (surgical or by catheter, excluding balloon aortic valvuloplasty); Moderate or severe aortic, mitral or tricuspid insufficiency; Native valve not calcified; Evidence of intracardiac mass.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
N/A
Safety and efficacy of the Inovare® Transcatheter Valve Implantation via femoralAortic Valve StenosisRBR-744myhkInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
Active, Not Recruiting
N/A
Transfemoral Implant of Inovare® Transcatheter ValveAortic Valve StenosisNCT05531578Braile Biomedica Ind. Com. e Repr. Ltda.60
Active, Not Recruiting
Phase 4
PMS plan is to provide local post marketing surveillance data regarding the safety of Medtronic CoreValveSystem FamilyHealth Condition 1: null- Symptomatic Aortic StenosisCTRI/2016/05/006957India Medtronic Pvt Ltd
Not Yet Recruiting
Phase 1
safety and efficacy of Haemodynamx device for aortic stenosisHealth Condition 1: I350- Nonrheumatic aortic (valve) stenosisCTRI/2024/05/067405Translumina Therapeutics LLP
Recruiting
N/A
Trans-catheter aortic valve implantatioSevere aortic valve stenosisJPRN-UMIN000006880Osaka University Graduate School of medicine Department of Cardiovascular Surgery, Department of Cardiology53